A DDI Study of JMKX000623 and Metformin Hydrochloride

NCT06066060 | Completed Phase 1

• 1 other identifier: JY-JM025-102
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

Brief Summary

A phase 1, single center, 1 sequence, 3 period, open label, multiple doses study to evaluate the drug-drug interaction of JMKX000623 tablet and metformin.

Conditions

Healthy; Drug-Drug Interaction

Outcome Measures

Primary Outcomes (2)

• Area Under the Dosing Time Curve During the Dosing Interval After Reaching Steady State（AUC0-tau）

  baseline through 4 days post-dose

• Maximum observed After Reaching steady state concentration (Css,max)

  baseline through 4 days post-dose

Secondary Outcomes (1)

• Adverse events (AEs)

  baseline through 4 days post-dose

Study Arms (1)

JMKX000623/Metformin/ JMKX000623+Metformin

EXPERIMENTAL

D1-D8, JMKX000623; D14-D19, Metformin; D20-D27, JMKX000623+Metformin

Drug: JMKX000623; Drug: Metformin

Interventions

JMKX000623 DRUG

JMKX000623, administered orally ;

JMKX000623/Metformin/ JMKX000623+Metformin

Metformin DRUG

Metformin,administered orally

JMKX000623/Metformin/ JMKX000623+Metformin

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Healthy Chinese subjects aged 18-45 years, male or female;
• Weight: male≥50.0kg, female≥45.0kg, 19.0 kg/m2≤BMI\<27.0 kg/m2;
• Normal or abnormal but without clinical significance reports of physical examinations, vital signs, clinical laboratory tests and others;
• Able to provide written informed consent voluntarily.

You may not qualify if:

• Suspected hypersensitivity to the main ingredients and excipients of JMKX000623 tablets, metformin hydrochloride tablets, or a history of allergy to drugs, food or other substances;
• History of clinically significant chronic gastrointestinal disease or history of gastrointestinal surgery (excluding appendectomy) that the investigator believes may affect drug absorption;
• Surgery within 3 months prior to screening that, in the judgment of the investigator, would interfere with the absorption, distribution, metabolism, or excretion of the drug, or surgery within 4 weeks prior to the use of the investigational drug, or planned surgery during the research;
• Took any prescription, over-the-counter, and herbal medications within 2 weeks prior to screening, or were within 5 half-lives of the medication at the time of screening, and plan to take other experimental medications other than those in this study for the duration of the research;
• Other conditions unsuitable for the study confirmed by the investigator.

Sponsors & Collaborators

• Jemincare: lead

Study Sites (1)

Huashan Hospital Fudan University

Shanghai, Shanghai Municipality, China

Location

MeSH Terms

Interventions

Metformin

Intervention Hierarchy (Ancestors)

Biguanides; Guanidines; Amidines; Organic Chemicals

Study Officials

• Xiaojie Wu, MD

  Huashan Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 13, 2023
• First Posted: October 4, 2023
• Study Start: September 17, 2023
• Primary Completion: November 6, 2023
• Study Completion: November 6, 2023
• Last Updated: April 25, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)